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Vitek 2 ast-n461 test kit, gram negative susceptibility testing - automated, reference number 424811

Official notice

30 Sept 2026

Last checked

6 Oct 2026

MediumFDA

An official FDA notice concerns VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-09-30. Lots: 1333393504, which. Recall numbers: Z-3231-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

97,680

Recall number

Z-3231-2026

Official notice

2026-09-30

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

1333393504, which

Other

UDI-DI 03573026637712

Event Ids

99749

Recall Numbers

Z-3231-2026

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Affected products

Product 1

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Units affected

97,680

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

DE · Germany

Affected area 4

LU · Luxembourg

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Biomerieux. Contact: Biomerieux Inc.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3231-2026

Event id

99749

Units affected

97,680

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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